E7-13649. U.S. Department of Agriculture, Agricultural Research Service; Determination of Nonregulated Status for Plum Genetically Engineered for Resistance to Plum Pox Virus

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are advising the public of our determination that a plum line developed by the U.S. Department of Agriculture's Agricultural Research Service, designated as transformation event C5, which has been genetically engineered for resistance to infection by plum pox virus, is no longer considered a regulated article under agency regulations governing the introduction of certain genetically engineered organisms. Our determination is based on our evaluation of data submitted by the Agricultural Research Service in their petition for a determination of nonregulated status, an analysis of other scientific data, and comments received from the public in response to a previous notice announcing the availability of the petition and an environmental assessment. This notice also announces the availability of our written determination and our finding of no significant impact.

EFFECTIVE DATE:

June 27, 2007.

ADDRESSES:

You may read the petition, environmental assessment, determination, finding of no significant impact, the comments we received on our previous notice, and our responses to those comments in our reading room or on the Internet. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue, SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call [phone] before coming. To view those documents on the Internet, go to http://www.regulations.gov, click on the “Advanced Search” tab, and select “Docket Search.” In the Docket ID field, enter APHIS-2006-0084, then click “Submit.” Clicking on the Docket ID link in the search results page will produce a list of all documents in the docket.

FOR FURTHER INFORMATION CONTACT:

Dr. Michael Watson, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [phone], [e-mail]. To obtain copies of the determination, petition, final environmental assessment (EA), or the finding of no significant impact (FONSI), contact Ms. Cynthia Eck at [phone]; [e-mail]. The determination, petition, final EA, response to comments, and FONSI are also available on the Internet at http://www.aphis.usda.gov/​brs/​aphisdocs/​04_​26401p.pdf and http://www.aphis.usda.gov/​brs/​aphisdocs/​04_​26401p_​ea.pdf.

SUPPLEMENTARY INFORMATION:

The regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,” regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered organisms and products are considered “regulated articles.”

The regulations in 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of 340.6 describe the form that a petition for a determination of nonregulated status must take and the information that must be included in the petition.

Background

On September 9, 2004, APHIS received a petition (APHIS Petition Number 04-264-01p) from the U.S. Department of Agriculture (USDA), Agricultural Research Service (ARS), Appalachian Fruit Research Station in Kearneysville, WV, requesting a determination of nonregulated status under 7 CFR part 340 for plum (Prunus domestica L.) designated as transformation event ARS-PLMC5-6 (C5), which has been genetically engineered to resist infection by plum pox virus (PPV). The ARS petition states that the subject plum should not be regulated by APHIS because it does not present a plant pest risk.

As described in the petition, the C5 plum has been genetically engineered with a sequence from PPV. This sequence was derived from the viral coat protein gene. The resistance to plum pox infection appears to be conferred through post transcriptional gene silencing. As a result of this mechanism, no detectable viral coat protein is found in the subject plum.

On May 16, 2006, APHIS published a notice in the Federal Register (71 FR 28296-28298, Docket No. APHIS-2006-0084) announcing the availability of the ARS petition and an environmental assessment (EA). APHIS solicited comments on whether the subject plum would present a plant pest risk and on the EA. APHIS received 1,725 comments by the close of the 60-day comment period, which ended on July 17, 2006. There were 1,708 comments that were opposed to a determination of nonregulated status for the C5 plum and 17 comments that supported it. The majority of comments in opposition to deregulation were the same or similar and came from organic grower or consumer groups, individual organic growers, individuals who favor organic agriculture, or individuals who oppose genetic engineering in general. The majority of those comments supporting the determination of nonregulated status were from academic researchers and State farm bureaus. APHIS has addressed the issues raised during the comment period and has provided responses to these comments as attachments to the finding of no significant impact.

Determination

Based on APHIS' analysis of the field, greenhouse, and laboratory data submitted by ARS, references provided in the petition, other relevant information described in the EA, and comments provided by the public, APHIS has determined that the C5 plum will not pose a plant pest risk for the following reasons: (1) The potential for gene flow and introgression are insignificant, therefore, the potential impacts from these are also insignificant; (2) the C5 plum is unlikely to thrive in unmanaged ecosystems, therefore, it is unlikely that there would be any weed impact from deregulation; (3) it does not produce any novel proteins or have any toxic properties that are likely to impact non-target organisms, including beneficial organisms and threatened or endangered species; (4) there is no apparent potential for significant impact on biodiversity; (5) the likelihood that the C5 plum would increase the development of new viruses or viruses with novel or altered properties is very low; and (6) if C5 plums were to be grown commercially, the impact on the environment would likely be no different than from cultivation of other domesticated plums.

APHIS has concluded that the subject plum and any progeny derived from hybrid crosses with other non-transformed plum varieties will be no more of a plant pest than plum varieties in traditional breeding programs that are not subject to regulation under 7 CFR part 340. The effect of this determination is that ARS C5 plum is no longer considered a regulated article under APHIS' regulations in 7 CFR part 340. Therefore, the requirements pertaining to regulated articles under those regulations no longer apply to the field testing, importation, or interstate movement of C5 plum or its progeny.

National Environmental Policy Act

To provide the public with documentation of APHIS' review and analysis of any potential environmental impacts associated with the determination of nonregulated status for ARS C5 plum, an EA was prepared. The EA was prepared in accordance with (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372). Based on that EA, APHIS has reached a finding of no significant impact with regard to the determination that ARS plum line C5 and lines developed from it are no longer regulated articles under its regulations in 7 CFR part 340. Copies of the EA and finding of no significant impact are available as indicated in the ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of this notice.

Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

Done in Washington, DC, this 29th day of June 2007.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.